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Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573AM1) (COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00132912
First received: August 19, 2005
Last updated: March 22, 2007
Last verified: March 2007
History of Changes
  Purpose

The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.


Condition Intervention Phase
Arterial Obstructive Diseases
Coronary Disease
 Drug: SCH 530348
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

Secondary Outcome Measures:
  • Incidence of bleeding throughout treatment and follow-up
  • Incidence of death and major adverse cardiac events

Estimated Enrollment: 1600
Study Start Date: August 2005
Estimated Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
  • A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
  • If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

  • Pregnancy
  • Recent stroke
  • Active internal bleeding or a history of a bleeding disorder
  • Increased risk of bleeding
  • Severe high blood pressure
  • Liver or kidney disease
  • Low platelet count
  • Condition such as alcoholism, mental illness, or drug dependence
  • Ongoing chest pain
  • Planned or ongoing treatment with a blood thinning medication
  • A serious condition or illness that would interfere with participation in the study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00132912     History of Changes
Other Study ID Numbers: P03573
Study First Received: August 19, 2005
Last Updated: March 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Platelets
Platelet Aggregation Inhibitors
Protease-Activated Receptor 1
Hemorrhage

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
 Heart Diseases
Arteriosclerosis
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013